Important note: Information in this article was accurate in 1997. The state of the art may have changed since the publication date.
PR Newswire, 810 Seventh Avenue, New York, NY 10019 - Friday September 26 4:04 PM EDT
"These results are promising because a majority of study participants showed a sustained increase in CD4+ cells, as well as potent viral load reductions from an average of 500,000 copies to below the limit of detection," remarked lead investigator Stefano Vella, M.D., Laboratory of Virology, Instituto Superiore di Sanita, Rome, Italy.
Significant differences were observed between treatment groups, with a better response in the triple combination arm. At 48 weeks, triple therapy with VIRAMUNE, AZT and ddI maintained a significant reduction in plasma HIV RNA levels with a mean 99 percent reduction from baseline, which was significantly greater than the AZT, ddI study arm. Additionally, CD4+ counts increased by 130 cells from baseline in the triple therapy arm compared to a 40 CD4+ cell increase observed in the AZT/ddI arm. Sixty percent of patients experienced viral load reductions below the limit of detection at one year.
Trial ISS 047
The ISS 047 trial is an Italian multi-center, randomized, phase II, double-blind, placebo-controlled clinical study comparing triple therapy with VIRAMUNE, AZT and ddI versus double therapy with AZT, ddI. Seventy-one (61 males, 10 females, mean age 37 years, range 23-62) previously untreated HIV-1 infected adults with entry CD4+ counts less than 200 cells/mm3 were enrolled in this 48-week study. The mean baseline plasma HIV-l RNA concentration for the VIRAMUNE, AZT, ddI arm was 5.7 log10 (500,000 copies/mL) and 5.5 log10 (300,000 copies/mL) for the AZT, ddI arm. Sixty-eight patients started treatment.
Upon enrollment, 28 patients were asymptomatic; 13 patients were symptomatic (without AIDS); 30 patients were diagnosed with clinical AIDS. Study drugs were: AZT (600 mg/day), ddI (400 mg/day); and VIRAMUNE (400 mg/day after 4 weeks at 200 mg/day).
VIRAMUNE
VIRAMUNE, the first NNRTI to receive marketing clearance by the Food and Drug Administration, is currently indicated for use in combination with nucleoside analogues for the treatment of HIV infected adults , who have experienced clinical and/or immunologic deterioration. VIRAMUNE is generally well tolerated. The most commonly reported adverse events associated with VIRAMUNE are rash, fever, nausea and headache. Severe and life-threatening skin reactions have occurred in patients treated with VIRAMUNE, including Stevens-Johnson Syndrome (SJS).
Viramune(R) nevirapine is marketed by Roxane Laboratories, Inc., headquartered in Columbus, OH. Viramune is a product of original research done at Boehringer Ingelheim Pharmaceuticals, Inc., located in Ridgefield, CT, which is a sister company of Roxane Laboratories, Inc.
SOURCE Roxane Laboratories, Inc.
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